Proposed Data Collections Submitted for Public Comment and Recommendations, 50820-50821 [E8-19968]
Download as PDF
<![CDATA[
50820
Federal Register / Vol. 73, No. 168 / Thursday, August 28, 2008 / Notices
Company/Jayhawk Works near
Pittsburg, Kansas, as an addition to the
Special Exposure Cohort (SEC) under
the Energy Employees Occupational
Illness Compensation Program Act of
2000. On August 15, 2008, the Secretary
of HHS designated the following class of
employees as an addition to the SEC:
All Atomic Weapons Employer (AWE)
employees who worked at Spencer Chemical
Company/Jayhawk Works near Pittsburg,
Kansas, from January 1, 1956 through
December 31, 1961 for a number of work
days aggregating at least 250 work days
occurring either solely under this
employment or in combination with work
days within the parameters established for
one or more other classes of employees in the
Special Exposure Cohort.
This designation will become
effective on September 14, 2008, unless
Congress provides otherwise prior to the
effective date. After this effective date,
HHS will publish a notice in the
Federal Register reporting the addition
of this class to the SEC or the result of
any provision by Congress regarding the
decision by HHS to add the class to the
SEC.
FOR FURTHER INFORMATION CONTACT:
Larry Elliott, Director, Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone 513–
533–6800 (this is not a toll-free
number). Information requests can also
be submitted by e-mail to
OCAS@CDC.GOV.
Dated: August 22, 2008.
Christine M. Branche,
Acting Director, National Institute for
Occupational Safety and Health.
[FR Doc. E8–19967 Filed 8–27–08; 8:45 am]
BILLING CODE 4160–17–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–08–08AL]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
The Natural History of Spina Bifida in
Children Pilot Project-New-National
Center on Birth Defects and
Developmental Disabilities (NCBDDD),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Spina Bifida (SB) is one of the most
common birth defects, affecting
approximately 2 per 10,000 live births
in the United States annually. To date,
there are no U.S. population-based
cohort studies or programs on the
natural history of SB. This is of
importance because persons with SB
often experience condition-specific
difficulties and secondary conditions
that detrimentally affect several aspects
of their lives. The long-term purpose of
this project is to increase the knowledge
about the natural history of Spina Bifida
by prospectively studying children who
were born with this potentially
disabling condition. We estimate to
enroll approximately 40 parents with a
child with Spina Bifida ages 3-, 4-, or 5years of age, and 20 of the children of
these forty parents. The data to be
collected will relate to medical concerns
prevalent among individuals with Spina
Bifida in the areas of neurology/
neurosurgery, urology, and orthopedics;
development and learning; nutrition
and physical growth; mobility and
functioning; general health; and family
demographics. Families interested in
participating can choose between
participating in a phone survey (no
more than 45 minutes) or an in-person
assessment (no more than 3 hrs). For
families who participate in the inperson assessment (estimated to be
twenty of the forty families), the child
will also be invited to participate in a
child-appropriate assessment.
Data will also be collected on the
actual recruitment process. Results from
the project will be evaluated and
disseminated to provide guidance for
states that are interested in following
children with Spina Bifida
prospectively. The proposed project is
the initial step to document the
development, the health status, and the
onset of complications among children
with SB in order that effective
interventions may be identified that will
ameliorate the course of this complex,
multi-system condition. Long-term
results will help determine if it would
be beneficial to systematically screen
children with Spina Bifida for certain
health-related educational and
developmental problems that these
children are at an increased risk of
experiencing and at what age such a
screening should be performed.
There will be no cost to the
respondents other than their time. The
total estimated annualized burden hours
are 97.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
jlentini on PROD1PC65 with NOTICES
Parents (phone survey) ...............................................................................................................
Parents (in-person assessment) ..................................................................................................
Child (in-person assessment) ......................................................................................................
SB Clinic Coordinator (recruitment effort) ...................................................................................
VerDate Aug<31>2005
17:36 Aug 27, 2008
Jkt 214001
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
E:\FR\FM\28AUN1.SGM
20
20
20
1
28AUN1
Number of
responses per
respondent
1
1
1
1
Average burden per
response
(in hours)
45/60
2.5
1.5
2
Federal Register / Vol. 73, No. 168 / Thursday, August 28, 2008 / Notices
Dated: August 22, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–19968 Filed 8–27–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Consolidated Vaccine Information
Materials for Multiple Infant Vaccines;
Revised Instructions for Use of
Vaccine Information Statements
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
jlentini on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: Under the National
Childhood Vaccine Injury Act (NCVIA)
(42 U.S.C. § 300aa–26), the CDC must
develop vaccine information materials
that all health care providers are
required to give to patients/parents prior
to administration of specific vaccines.
CDC seeks written comment on a
proposed new vaccine information
statement that consolidates the six
vaccine information statements for the
following childhood vaccines: DTaP,
Haemophilus influenzae type b,
inactivated polio vaccine,
pneumococcal conjugate vaccine,
hepatitis B, and rotavirus. This
consolidated Vaccine Information
Statement would be available to be used
by vaccination providers as an
alternative to providing the six
individual Vaccine Information
Statements for the same vaccines. On
October 4, 2007, CDC published a notice
in the Federal Register (72 FR 56765)
seeking public comments on the
proposed consolidated vaccine
information materials. The 60 day
comment period ended on December 3,
2007. Following review of the
comments submitted and consultation
as required under the law, CDC has
finalized these vaccine information
materials. The final materials, and
revised instructions for their use and for
use of materials for other covered
vaccines, are contained in this notice.
DATES: Beginning August 28, 2008, each
health care provider who administers
vaccine that contains diphtheria,
tetanus, pertussis, hepatitis B,
pneumococcal conjugate, inactivated
polio, Haemophilus influenzae type b,
or rotavirus vaccines may, prior to
administration of each dose of these
vaccines, provide a copy of the vaccine
VerDate Aug<31>2005
17:36 Aug 27, 2008
Jkt 214001
information materials contained in this
notice, dated January 30, 2008, to the
parent or legal representative of any
child to whom such provider intends to
administer the vaccines, in lieu of
providing vaccine information materials
for each individual vaccine.
FOR FURTHER INFORMATION CONTACT:
Anne Schuchat, M.D., Director, National
Center for Immunization and
Respiratory Diseases, Centers for
Disease Control and Prevention,
Mailstop E–05, 1600 Clifton Road, NE.,
Atlanta, Georgia 30333, telephone (404)
639–8200.
The
National Childhood Vaccine Injury Act
of 1986 (Pub. L. 99–660), as amended by
section 708 of Public Law 103–183,
added section 2126 to the Public Health
Service Act. Section 2126, codified at 42
U.S.C. 300aa–26, requires the Secretary
of Health and Human Services to
develop and disseminate vaccine
information materials for distribution by
all health care providers in the United
States to any patient (or to the parent or
legal representative in the case of a
child) receiving vaccines covered under
the National Vaccine Injury
Compensation Program.
Development and revision of the
vaccine information materials, also
known as Vaccine Information
Statements (VIS), have been delegated
by the Secretary to the Centers for
Disease Control and Prevention (CDC).
Section 2126 requires that the materials
be developed, or revised, after notice to
the public, with a 60-day comment
period, and in consultation with the
Advisory Committee on Childhood
Vaccines, appropriate health care
provider and parent organizations, and
the Food and Drug Administration. The
law also requires that the information
contained in the materials be based on
available data and information, be
presented in understandable terms, and
include:
(1) A concise description of the
benefits of the vaccine,
(2) a concise description of the risks
associated with the vaccine,
(3) a statement of the availability of
the National Vaccine Injury
Compensation Program, and
(4) such other relevant information as
may be determined by the Secretary.
The vaccines initially covered under
the National Vaccine Injury
Compensation Program were diphtheria,
tetanus, pertussis, measles, mumps,
rubella and poliomyelitis vaccines.
Since April 15, 1992, any health care
provider in the United States who
intends to administer one of these
covered vaccines is required to provide
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
50821
copies of the relevant vaccine
information materials prior to
administration of any of these vaccines.
Hepatitis B, Haemophilus influenzae
type b (Hib), varicella (chickenpox),
pneumococcal conjugate, hepatitis A,
meningococcal conjugate and
polysaccharide, rotavirus, human
papillomavirus (HPV), and trivalent
influenza vaccines have subsequently
been added to the National Vaccine
Injury Compensation Program. Use of
the Vaccine Information Statements
applicable to all of these vaccines,
[except meningococcal, rotavirus and
HPV,] is also required. [(Interim
versions of Vaccine Information
Statements for meningococcal, rotavirus
and HPV vaccines are available for
discretionary use pending completion of
the statutory process for finalizing VISs
applicable to those vaccines.)]
Instructions for use of the vaccine
information materials and copies of the
materials can be found on the CDC Web
site at: https://www.cdc.gov/vaccines/
pubs/vis. In addition, single cameraready copies are available from State
health departments. A list of State
health department contacts for obtaining
copies of these materials is included in
a December 17, 1999 Federal Register
notice (64 FR 70914).
Consolidated Vaccine Information
Materials
With six vaccines recommended for
infants from birth through 6 months of
age—all covered by the National
Vaccine Injury Compensation
Program—CDC, as required under 42
U.S.C. 300aa–26, developed Vaccine
Information Statements for each of those
vaccines. CDC proposed an alternative
consolidated Vaccine Information
Statement covering those six vaccines in
one document, which providers could
choose to use instead of the existing
individual Vaccine Information
Statements for the same vaccines.
Following consultation as required
under the law and review of comments
submitted, these vaccine information
materials have been finalized and are
contained in this notice. They are
entitled Your Baby’s First Vaccines:
What You Need to Know, and are dated
January 30, 2008. CDC has also revised
the Instructions for the Use of Vaccine
Information Statements. The revised
instructions, dated May 12, 2008, are
included in this notice. These
instructions and copies of the materials
for all covered vaccines can also be
found on the CDC Web site at: https://
www.cdc.gov/vaccines/pubs/VIS.
*
*
*
*
*
E:\FR\FM\28AUN1.SGM
28AUN1
]]>Agencies
[Federal Register Volume 73, Number 168 (Thursday, August 28, 2008)]
[Notices]
[Pages 50820-50821]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19968]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-08-08AL]
Proposed Data Collections Submitted for Public Comment and
Recommendations
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-6974.
Written comments should be received within 30 days of this notice.
Proposed Project
The Natural History of Spina Bifida in Children Pilot Project-New-
National Center on Birth Defects and Developmental Disabilities
(NCBDDD), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Spina Bifida (SB) is one of the most common birth defects,
affecting approximately 2 per 10,000 live births in the United States
annually. To date, there are no U.S. population-based cohort studies or
programs on the natural history of SB. This is of importance because
persons with SB often experience condition-specific difficulties and
secondary conditions that detrimentally affect several aspects of their
lives. The long-term purpose of this project is to increase the
knowledge about the natural history of Spina Bifida by prospectively
studying children who were born with this potentially disabling
condition. We estimate to enroll approximately 40 parents with a child
with Spina Bifida ages 3-, 4-, or 5-years of age, and 20 of the
children of these forty parents. The data to be collected will relate
to medical concerns prevalent among individuals with Spina Bifida in
the areas of neurology/neurosurgery, urology, and orthopedics;
development and learning; nutrition and physical growth; mobility and
functioning; general health; and family demographics. Families
interested in participating can choose between participating in a phone
survey (no more than 45 minutes) or an in-person assessment (no more
than 3 hrs). For families who participate in the in-person assessment
(estimated to be twenty of the forty families), the child will also be
invited to participate in a child-appropriate assessment.
Data will also be collected on the actual recruitment process.
Results from the project will be evaluated and disseminated to provide
guidance for states that are interested in following children with
Spina Bifida prospectively. The proposed project is the initial step to
document the development, the health status, and the onset of
complications among children with SB in order that effective
interventions may be identified that will ameliorate the course of this
complex, multi-system condition. Long-term results will help determine
if it would be beneficial to systematically screen children with Spina
Bifida for certain health-related educational and developmental
problems that these children are at an increased risk of experiencing
and at what age such a screening should be performed.
There will be no cost to the respondents other than their time. The
total estimated annualized burden hours are 97.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Parents (phone survey).......................................... 20 1 45/60
Parents (in-person assessment).................................. 20 1 2.5
Child (in-person assessment).................................... 20 1 1.5
SB Clinic Coordinator (recruitment effort)...................... 1 1 2
----------------------------------------------------------------------------------------------------------------
[[Page 50821]]
Dated: August 22, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E8-19968 Filed 8-27-08; 8:45 am]
BILLING CODE 4163-18-P
